A Study Evaluating Efficacy, Toxicity, Harvest Yield and Quality of Life
Four monthly treatments with pegylated liposomal doxorubicin, thalidomide and dexamethasone for newly diagnosed myeloma patients as induction therapy prior to high dose chemotherapy and autologous stem cell transplant.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Doxil® (Pegylated Liposomal Doxorubicin), Dexamethasone Plus Thalidomide (Ddt) in Previously Untreated Multiple Myeloma: A Study Evaluating Efficacy, Toxicity, Harvest Yield and Quality of Life|
- Response rate [ Time Frame: At cycle 4 and end of study ] [ Designated as safety issue: No ]
- Toxicity [ Time Frame: weekly during treatment, end of study ] [ Designated as safety issue: Yes ]
|Study Start Date:||November 2002|
|Estimated Study Completion Date:||July 2009|
|Estimated Primary Completion Date:||April 2009 (Final data collection date for primary outcome measure)|
Doxil, Thalidomide, Dexamethasone
Doxil 40 mg/m2 IV day 1
Other Name: pegylated liposomal doxorubicinDrug: Thalidomide
50-100 mg day 1-28
Other Name: thalidomidDrug: Dexamethasone
Dexamethasone 40 mg day 1-4 and 15-18
Other Name: decadron
Multiple myeloma (MM) is an incurable hematological malignancy of plasma cell origin. Plasma cell clonality and dysfunctional immunoglobulin production characterize the disease. The consequences of abnormal plasma cell growth are manifested by a myriad of symptoms and signs that often have significant impact on the patient's quality of life. These include pancytopenia secondary to predominant distribution of tumor cells within the bone marrow along with many other effects.
This study is focused on the efficacy of Doxil® (pegylated liposomal doxorubicin) with low dose Dexamethasone and Thalidomide (Ddt) in previously untreated patients with multiple myeloma.